The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Evergreen Non-sterile Powdered Latex Examination Glove.
| Device ID | K974191 |
| 510k Number | K974191 |
| Device Name: | EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN. BHD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Contact | Moh Ung Nang |
| Correspondent | Leonard Frier MET LABORATORIES, INC. 914 WEST PATAPSCO AVE. Baltimore, MD 21230 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1997-11-10 |
| Decision Date | 1997-12-24 |
| Summary: | summary |